Imdur

NDA 20225, held by Schering Plough. Isosorbide Mononitrate.

As of Nov 13, 2026, NDA 20225 (Imdur), held by Schering Plough, was first approved by FDA on Aug 12, 1993, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 12, 1993
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 12, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Imdur30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Isosorbide Mononitrate	DiscontinuedReference drug
Imdur60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Isosorbide Mononitrate	DiscontinuedReference drug
Imdur120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Isosorbide Mononitrate	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Jan 22, 2003	Supplement 8Labeling · Standard review	Approved	Letter
Feb 17, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Jan 27, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 18, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 23, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 17, 1997	Supplement 4Labeling · Standard review	Approved	None posted
Mar 6, 1996	Supplement 2Labeling · Standard review	Approved	None posted
Mar 30, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 12, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20225
Drugs@FDA: Overview at FDA
Company: Schering-Plough

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters